I. The Field of the Invention
The present invention relates to an apparatus, system, and method for measuring particles that are generated from medical devices or instruments that are delivered into or utilized within the body of a patient, such as a human patient. More particularly, the apparatus, system, and method can be used to perform real-time measurement of particles generated from medical devices or instruments in a manner and condition that closely or exactly mimics the manner and condition at which the medical devices or instruments would actually be utilized within the body of the patient. The apparatus, system, and methods are designed to study the release of particles from medical devices or instruments in a simulated clinical or surgical procedure that is closely related to the actual conditions in which the medical devices or instruments would be used.
II. The Related Technology
Stents, grafts, catheters, and a variety of other medical devices or instruments are well known to be used in various surgical and interventional procedures. The medical devices are usually delivered or utilized within the body of an animal, such as a human, for treating aneurysms, lining or repairing vessel walls, filtering or controlling fluid flow, expanding or scaffolding occluded or collapsed vessels, and for a variety of other surgical or interventional procedures. The medical devices, either alone or in combination with other medical devices, are often delivered into or used in virtually any accessible body lumen of an animal, and such medical devices can be deployed by any of a variety of recognized methodologies.
While the medical devices or instruments may be designed to be utilized within the body of an animal, such medical devices or instruments may inadvertently be susceptible to malfunctions that compromise the surgical or interventional procedures and compromise the health of the animal in which the medical device or instrument is employed. It has been established that medical devices and instruments that are prepared by industrial manufacturing methods for use within the body of an animal can crack, break, splinter, degrade, bend, flex, generate particles, and the like during use, all of which may result in particles being released from the medical device or instrument. When a medical device or instrument generates particles during deployment or use, such particles can cause additional complications and can compromise the health of the animal. For example, particle generation can cause organ damage, and increase the potential of stroke or heart attack. Thus, it can be desirable to determine whether or not a medical device or instrument generates particles during deployment or use, and it can further be desired to determine the amount of particles that are generated in these instances.
The current procedures for determining whether particles are generated from medical devices and measuring the amount of such generated particles are batch methods where the counting is done offline after the particles are generated. However, such procedures can be susceptible to error because the particles may fall out of solution or the sample may not contain an accurate representation of the entire population of particles. While all of the particles generated by a medical device could be counted in each procedure, this would be a monumental task that is not practical. Counting all particles in the visual method using a microscope would require an overly-burdensome amount of manual counting, time, and eye strain. The method using a current displacement-based particle counter (e.g., Coulter® counters) count discrete volumes making it very difficult to count all the particles without inducing air bubble errors. Laser counters that are used as batch counters have the same concerns as the current displacement-based particle counters. Thus, it is desirable for a procedure to count substantially all particles generated in real time rather than counting particles in a batch procedure, and there exists a need in the art for a way to measure the amount and size of particles generated from medical devices when utilized in mammals.
Therefore, it would be advantageous to have an apparatus, system, and method for determining whether a medical device generates particles or measuring the amount of such particles in a real-time or steady-state process. Additionally, it would be advantageous for the apparatus, system, and method to simulate the conditions imposed on a medical device when being delivered or utilized within the body of a patient. Further, it would be advantageous for the apparatus, system, and method to employ a stream of fluid that mimics or simulates blood flow so that any generated particles can be identified or measured in simulated blood flow.